Perfluorohexyloctane Ophthalmic Solution: A Review in Dry Eye Disease.

IF 13 1区 医学 Q1 PHARMACOLOGY & PHARMACY Drugs Pub Date : 2024-04-01 Epub Date: 2024-03-30 DOI:10.1007/s40265-024-02016-5
Amy Zhuang-Yan, Yahiya Y Syed
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Abstract

Perfluorohexyloctane ophthalmic solution (Miebo®) is a single-entity, water-, steroid- and preservative-free, first-in-class semifluorinated alkane that is approved in the USA for the treatment of the signs and symptoms of dry eye disease (DED). DED is often linked with meibomian gland dysfunction (MGD), which causes an excessive evaporation of tears. Perfluorohexyloctane ophthalmic solution stabilizes the lipid layer of the tear film and inhibits tear evaporation by forming a monolayer at the air-liquid interface. In the phase III GOBI and MOJAVE trials in adults with DED associated with MGD, one drop of perfluorohexyloctane ophthalmic solution instilled in each eye four times daily over 8 weeks resulted in statistically significant and clinically meaningful improvements in the signs and symptoms of DED compared with hypotonic saline (0.6%). The agent was generally well tolerated, with most ocular adverse events being mild or moderate in severity. The efficacy and tolerability of perfluorohexyloctane ophthalmic solution was sustained for up to 52 weeks in an extension study (KALAHARI). As the first and currently the only prescription treatment approved in the USA directly addressing the pathophysiology of excessive tear evaporation, perfluorohexyloctane ophthalmic solution is a valuable emerging option for the management of DED.

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全氟己基辛烷眼药水:干眼症综述。
全氟己基辛烷眼科溶液(Miebo®)是一种单一成分、不含水、类固醇和防腐剂的一流半氟化烷烃,在美国被批准用于治疗干眼症(DED)的症状和体征。干眼症通常与睑板腺功能障碍(MGD)有关,后者会导致泪液过度蒸发。全氟己基辛烷眼药水可稳定泪膜脂质层,并通过在气液界面形成单层来抑制泪液蒸发。在 GOBI 和 MOJAVE III 期试验中,与低渗生理盐水(0.6%)相比,在 8 周内每只眼睛滴入一滴全氟己基正辛烷眼药水,每天四次,可显著改善 DED 的体征和症状。该药物的耐受性普遍良好,大多数眼部不良反应为轻度或中度。在一项扩展研究(KALAHARI)中,全氟己基辛烷眼药水的疗效和耐受性持续了长达 52 周。全氟己基辛烷眼药水是美国批准的第一种也是目前唯一一种直接针对泪液过度蒸发的病理生理学的处方治疗药物,是治疗 DED 的一种有价值的新选择。
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来源期刊
Drugs
Drugs 医学-毒理学
CiteScore
22.70
自引率
0.90%
发文量
134
审稿时长
3-8 weeks
期刊介绍: Drugs is a journal that aims to enhance pharmacotherapy by publishing review and original research articles on key aspects of clinical pharmacology and therapeutics. The journal includes: Leading/current opinion articles providing an overview of contentious or emerging issues. Definitive reviews of drugs and drug classes, and their place in disease management. Therapy in Practice articles including recommendations for specific clinical situations. High-quality, well designed, original clinical research. Adis Drug Evaluations reviewing the properties and place in therapy of both newer and established drugs. AdisInsight Reports summarising development at first global approval. Moreover, the journal offers additional digital features such as animated abstracts, video abstracts, instructional videos, and podcasts to increase visibility and educational value. Plain language summaries accompany articles to assist readers with some knowledge of the field in understanding important medical advances.
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